A Pilot Study of Cyclin B1 Peptide-Pulsed Autologous Dendritic Cell Vaccine for Patients With Resectable Non-Small Cell Lung Cancer
In the currently proposed study, patients will receive the first dose of the vaccine
approximately 2 weeks prior to surgery. The second dose will be administered about 3-4 weeks
following surgery. A booster dose of the vaccine will be given 6 months after the 2nd
vaccine. The tumor tissue and serum will be studied for immunological responses following
therapy with the vaccine. Patients are allowed to receive adjuvant chemotherapy if
indicated. The choice of the chemotherapy regimen will be at the discretion of the treating
physician, preferably 3-4 cycles of platinum combination regimen. The vaccine should be
administered at least 2 weeks before chemotherapy is initiated.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the ability of cyclin B1 peptide pulsed autologous dendritic cell vaccine to induce an immune response.
One week after second vaccine
Chandra P. Belani, MD
Milton S. Hershey Medical Center
United States: Food and Drug Administration